Posted on 19th January 2020
Senior Regulatory Affairs Specialist
Curium was formed in 2017 through the union of IBA Molecular and Mallinckrodt Nuclear Medicine LLC. Curium is a world-class nuclear medicine solutions provider with over 100 years of combined industry experience. We are proud to service over 14 million patients worldwide each year and strive to provide best-in-class quality products and exceptional, reliable service.
Our diverse group of industry experts is unified under one strong and singular focus – to develop, manufacture and supply SPECT, PET and therapeutic radiopharmaceuticals to customers around the globe. In fact, we have over 6,000 customers in over 70 countries world-wide.
At Curium, every single dose counts in helping doctors and patients diagnose and treat disease. That means every single employee counts toward meeting this unified objective to help each patient live “Life Forward”. We have an amazing team that lives by our core values every single day – integrity, commitment and collaboration. Come grow with us!
Summary of Position
Prepare Investigational New Drug (IND), Abbreviated New Drug Applications (ANDA), New Drug Applications (NDA), and other regulatory applications for drugs; work collectively with multidisciplinary teams for assimilation of relevant information and assist junior-level associates on assembling components of the application.
Anticipate regulatory consequences; develop and maintain knowledge of the history, manufacture, and materials of assigned products and product lines to assess the consequences of regulatory changes for the product and the regulatory consequences of the changes in the manufacture, materials, or marketing of the product. Maintain high level of knowledge of regulations, the regulatory process, and the application of regulations to assigned products. Represent Regulatory on Core Teams in the Product Development Process; develop regulatory strategy for projects in various stages of development; negotiate agreement to novel approaches to problem solving; act as a liaison to other regulatory functions and clinical team to provide cohesive strategy and timelines for product development process. Liaise with the Food and Drug Administration (FDA) and contacts outside of company. Prepare submissions in an electronic document management system. Process, interpret and provide recommendations for complex, unusual issues. Critically review documentation for regulatory submissions and provide input for necessary revisions.
· Bachelor Degree in Chemistry, Pharmacy, Biology, Life Science or related degree
· Three years of experience working in pharmaceutical Regulatory Affairs
· Three years of experience preparing Food and Drug Administration submissions, including Abbreviated New Drug Applications (ANDA), New Drug Applications (NDA), and Drug Master Files, including reviewing work of others for technical adequacy and interacting with reviewers at the agency
· Demonstrated knowledge of Chemistry, Manufacturing, and Controls (CMC) documentation
· Three years of experience with publishing software and eCTD publishing process
· Demonstrated understanding of regulatory application processes and the basis of regulations
· Demonstrated knowledge of federal acts and regulations affecting proposed and marketed products
Mail résumés to Michael Gruen, Curium US LLC, 2703 Wagner Place, Maryland Heights, MO 63043.
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
Equal Opportunity Employer
Curium is an equal opportunity employer and believes everyone deserves respect, dignity and equality. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.